European Medicines Agency (EMA) published a number of recommendations to deal with the problems concerning the production and supply of medicines, included in the list of critical medicines of the EU.
They were developed by The Medicines Shortage Management Group (MSSG) of EMA and will facilitate the availability and supply of critical medicines for human usefor which supply chain vulnerabilities have been identified.
The Union list of critical medicines includes medicines for human use for which shortages must be avoided as they are critical for the proper functioning of EU healthcare systems and the lack of to them would lead to interruption of treatment and risk of serious harm to patients.
Among the recommendations to Marketing Authorization Holders (MAHs) are increasing production capacity and diversifying suppliers in the supply chain (for example by adding alternative production sites), as well as monitoring drug demand and supply forecasts and available stock throughout the supply chain. The possibility of requesting a plan to prevent shortages of medicines on the Union list of critical medicines is also being considered.
The monitoring of the forecast for the demand for medicinal products is essential for proper adjustments in production and distribution to avoid or at least mitigate the impact of shortages, the agency noted. MAHs should implement appropriate indicators throughout their supply chain to identify early signals of potential shortagesincluding demand peaks. The goal is to implement mitigation measures to avoid shortages or reduce the impact on patients and health systems, the agency recommends.
The MSSG can recommend to the European Commission and the use of mechanisms to facilitate the central contracting and central or joint purchasing of medicines for EU/EEA member states.
Source: https://www.ema.europa.eu/en/news/new-recommendations-strengthen-supply-chains-critical-medicines
